Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

Phase 4

• Conditions: Mechanical Ventilation for More Than 48 Hours.
• Interventions: Drug: 0.12% chlorhexidine solution; Drug: Placebo

• Registration Number: NCT01883596
• Lead Sponsor: Sinaloa Pediatric Hospital

Brief Summary

To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Detailed Description

Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Children aged 1 month to 18 years admitted to the intensive care unit.
• Intubated for more than 48 hours.

Exclusion Criteria

• Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
• Allergy to chlorhexidine.
• Known immune deficiency.

Elimination Criteria:

• Transfer to another hospital.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.12% Chlorhexidine	0.12% chlorhexidine solution	Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs.
Placebo	Placebo	7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.

Primary Outcome Measures

Name	Time	Method
Incidence of ventilator associated pneumonia	Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks

Secondary Outcome Measures

Name	Time	Method
Mortality	Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Days of mechanical ventilation	From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks
Length of stay	From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks

Trial Locations

Locations (1)

Sinaloa Pediatric Hospital; 🇲🇽 Culiacan, Sinaloa, Mexico